Mechanical anastomosis system for hollow structures

ABSTRACT

A system for making anastomoses between hollow structures by mechanical means is provided with a device in the shape of an annular or tubular element comprising circumferentially provided means, such as pin-shaped elements, for joining the abutting walls of the hollow structures together. An applicator is intended for moving said annular or tubular element in position and activating the joining means thereof, so as to make the anastomosis. Possibly, intraluminal joining means can be inserted without using an annular or tubular element.

The present invention relates to a system for making anastomoses betweenhollow structures by mechanical means, and also to a device and anapplicator for use therewith.

Such a system may for example be used when making a bypass pastnarrowings or occlusions of arteries caused by arteriosclerosis. Thereare now various possibilities of remedying such constrictions orocclusions.

If the constriction or occlusion takes place in a coronary artery, theleast radical method is to dilate the constriction by means of a PTCAprocedure (Percutaneous Transluminal Coronary Angioplasty), which may ormay not be followed by the placing of an intraluminal stent. This is notalways possible, however.

On the other hand, as already mentioned before, it is possible to make abypass by means of surgery. To this end an artery (arteria mammariainterna) or a vein from the leg (vena saphena magna) may be used, forexample. An anastomosis is thereby made in the coronary artery, distallyof the constriction or occlusion. The interconnection between thevessels is then manually sutured by means of 8 to 20 stitches. Saidanastomosis may be a side-to-side or an end-to-side anastomosis. Thenatural origin of the arteria mammaria interna is usually preserved, sothat such a bypass will directly be functional. A bypass made of a venasaphena magna will have to be sutured separately in the aorta (theso-called proximal anastomosis). Due to the small diameter of coronaryarteries (1-3 mm), it is generally decided to stop the heart in order tobe able to carry out the anastomosis precisely and safely. The bloodcirculation is kept going by a heart-lung machine during this time.Although this is a well-tried and reasonably safe method, it has certaindrawbacks. Thus, the use of the heart-lung machine has a number of sideeffects for the patient, as a result of which recovery following surgerytakes more time. Moreover, the necessary disposables for the heart-lungmachine are costly.

At present, techniques are available for a number of readily accessiblecoronary arteries to make manually sutured vascular connections to abeating, functioning heart. Generally, a device which more or lessimmobilizes a small area of the heart by mechanical means is usedthereby. The drawbacks of said method are the fact that only a limitednumber of places on the heart can be reached and the fact that part ofthe heart is temporarily anaemic, because it is necessary to stop thecirculation through the blood vessel to be treated for 8-15 minutes.

The object of the present invention is to provide a system for makinganastomoses between hollow structures by mechanical means, which willmake it easier to make mechanical anastomoses.

In order to accomplish that objective, the system according to theinvention is characterized by a device in the shape of an annular ortubular element comprising joining means provided circumferentiallythereon for joining the abutting walls of the hollow structurestogether, as well as an applicator for moving said annular or tubularelement in position and activating the joining means thereof.

The system according to the invention makes it possible to effect ananastomosis faster and more easily by placing an annular or tubularelement comprising joining means with the aid of said applicator, whichjoining means are also activated by said applicator, in such a mannerthat the anastomosis is made.

The system according to the invention has a wide range of applications,due to the fast and accurate manner of making an anastomosis. Thus, thefollowing applications are conceivable:

“port access surgery”, such as laparoscopic or thoracoscopic vascularreconstructions;

small, precise vascular connections to a moving organ, as in heartsurgery; and

vascular reconstructions wherein the circulation through the supplyingvessel may only be shut off for a very short period of time, as inneurosurgery.

Of course, it is also possible to use the invention to make anastomosesbetween other hollow structures.

The invention also comprises embodiments of devices and applicators foruse in the above-described system for making anastomoses by mechanicalmeans.

The device of the system according to the invention can be usedintraluminally as well as extraluminally, and it can be adapted both forside-to-side anastomoses and for end-to-side anastomoses. The joiningmeans are preferably pin-shaped elements, whereby pairs of pin-shapedelements may be considered, which can function as staples, orindependently operating pin-shaped elements, which can be fixed to thevessel walls by being deflected. Preferably, the tubular or annularelements for intraluminal use can expand from a smaller startingdiameter to a final joining diameter, whereby the joining means can beactivated either automatically upon expansion or individually. Theelements may have a circular cross-section, but also an ellipticalcross-section, for example, so that the resulting anastomosis will alsohave a circular or an elliptical cross-section.

The invention furthermore comprises a method for making intraluminalside-to-side or side-to-end anastomoses between hollow structures bymechanical means, which is characterized by providing an applicator andassociated joining means for joining the abutting walls of the hollowstructures together, placing said joining means around the applicator,inserting said applicator and said joining means into one of said hollowstructures to a location internally of the abutting walls of the hollowstructures, and activating said applicator, and thus passing saidjoining means through said abutting walls or clamping said joining meansagainst said abutting walls for the purpose of keeping said abuttingwalls in sealing contact with each other.

With this method, a number of loose staples may be used as the joiningmeans.

The invention will be explained in more detail hereafter with referenceto the drawings, which show embodiments of the invention.

FIG. 1 is a perspective view of a first embodiment of the device formaking anastomoses by mechanical means according to the invention,showing the starting position thereof.

FIG. 2 is a side view of the device according to FIG. 1.

FIG. 3 is an axial view of the device according to FIG. 1.

FIG. 3a shows an axial view of a device similar to that shown in FIG. 3except which has an elliptical cross-section.

FIG. 4 is a perspective view of the device corresponding with FIG. 1,wherein the device is shown in the joining position, however.

FIGS. 5 and 6 are a side view and an axial view, respectively, of thedevice of FIG. 4.

FIG. 6a shows an axial view of the device of FIG. 3a in the joiningposition.

FIGS. 7-12 are views corresponding with FIGS. 1-6 of a second embodimentof the device according to the invention. From the axial views shown inFIGS. 9 and 12, it can be seen that the second embodiment of the deviceaccording to the invention has a polygonal cross-section.

FIG. 13 is a side view of an applicator for use with the deviceaccording to FIGS. 7-12, showing the starting position thereof.

FIG. 14 is a perspective view of the applicator of FIG. 13, with thedevice according to FIGS. 7-12, which is shown in the starting positionthereof, in mounted position thereon.

FIG. 15 is a side view corresponding with FIG. 13, wherein theapplicator is shown in the joining position, however.

FIGS. 16-21 are views corresponding with FIGS. 1-6 of a third embodimentof the device according to the invention.

FIGS. 22-24 are views corresponding with FIGS. 13-15 of an applicatorfor use with the device according to FIGS. 16-21.

FIG. 25 is a schematic side view, partially in sectional view, of analternative applicator for use with the device according to FIGS. 1-6 or7-12.

FIG. 26 is a partial front view of the applicator of FIG. 25.

FIG. 27 is a view corresponding with FIG. 25, wherein the applicator isshown in the expanded position, however.

FIGS. 28-30 are sectional views and elevational views respectivelycorresponding with FIGS. 25-27 of a variant of an applicator for usewith a device according to FIGS. 16-21.

FIGS. 31-33 are partially cut-away side views of another variant of theapplicator, for example for use with a device according to FIGS. 1-6 or7-12, showing three different positions thereof.

FIG. 34 is a side view of a variant of the extendible arms of theapplicator of FIG. 31.

FIGS. 35, 36 are perspective views of the applicator of FIG. 31, showingthe two extreme positions thereof.

FIGS. 37, 38 and 39, 40 are side views and perspective views,respectively, of yet another variant of the applicator according to theinvention for use with a device according to FIGS. 1-6 or 7-12, forexample, showing the two extreme positions thereof.

FIG. 41 is a highly schematic perspective view of blood vesselsinterconnected by side-to-side anastomose with loose staples.

FIGS. 1-6 show a first embodiment of a device for making anastomosesbetween hollow structures, in particular arteries or veins, bymechanical means.

In the present case, the device is a one-piece tubular or annularelement 1, which is made of a biocompatible and plastically deformablematerial, for example a tantalum alloy or another material used inmedical technology. Annular element 1 may be considered to be anassembly of two zigzag-like elongated elements 2 and 3 which extendsubstantially in circumferential direction but not along the contourline, which elements are interconnected at the facing vertices, thusforming a ring of diamond-shaped structures 4. Present on the verticesof the zigzag-like elements 2, 3 that face away from each other arepin-shaped elements 5, 6, which are provided with sharp tips 7 at theirends facing away from annular element 1, wherein the tips 7 of twoassociated pin-shaped elements 5, 6 forming a pair are directed towardseach other. The pin-shaped elements may be straight, but also curved orangular, for example, thus forming staples which are C-shaped, as itwere, whilst the pin-shaped elements may also be shaped more like lips.

Since annular element 1 is formed from elongated elements 2, 3, whoselength in circumferential direction is greater than that of annularelement 1 in the position as shown in FIGS. 1-3, and since elements 2and 3 are capable of deformation, it is possible to expand annularelement 1 from the starting position as shown in FIGS. 1-3 to a finalposition, or joining position, as shown in FIGS. 4-6. In said joiningposition, annular element 1 has a diameter which is associated with adiameter which is at most equal to the length of elongated elements 2,3. It would also be possible, of course, to expand annular element 1only to a smaller diameter.

As is apparent from a comparison between FIGS. 4-6 and 1-3, thediamond-shaped structures 4 are deformed to a straighter shape, seen incircumferential direction, wherein the vertices comprising thepin-shaped elements 5, 6 have been moved closer together, such that thepoints 7 of pin-shaped elements 5, 6 of one pair engage each other. Thismovement of points 7 of pin-shaped elements 5 and 6 towards each othercan be used for joining together or clamping together the walls of thehollow structures for the purpose of making the anastomosis, as will beexplained in more detail hereafter.

Since the joining means in the form of pin-shaped elements 5, 6comprising points 7 are automatically activated upon expansion ofannular element 1 from the first starting diameter to the second, largerjoining diameter, it is possible to use a very simple applicator, whichconsists of a shank-like element for insertion and manipulation, at thedistal end of which a head is present, whose diameter can be enlarged.The head may therefore consist of an inflatable balloon, as is knownfrom balloon catheters, or of a mechanically expandable head or thelike.

In this embodiment, the following method is used for making ananastomosis.

In the case of a side-to-side anastomosis, incisions are made in thevessel to be bypassed and in the bypass at opposite locations. Theapplicator is inserted through the open free end of the bypass andpassed through the incisions, possibly by means of a guide wire. Annularelement 1 is thereby positioned so that one end of annular element 1 ispositioned in one vessel and the other end of annular element ispositioned in the other vessel, so that pin-shaped elements 5 and 6 arepositioned on either side of the walls of the adjacent vessels. Whenexpansion of the applicator causes annular element 1 to expand from thefirst starting diameter to the second, larger joining diameter, annularelement 1 is radially enlarged on the one hand and axially shortened onthe other end, wherein the pin-shaped elements 5 and 6 move together,eventually clamping down the walls of the vessels round the incisions,with points 7 becoming fixed in the walls of the vessels. The passagebetween the two vessels is determined by the diameter of annular element1, so that said element functions both to keep the walls of the twovessels together and to keep the passage open. When annular element 1has reached its joining position, the head of the applicator is reducedto a smaller diameter again and the applicator is withdrawn from thebypass lumen, after which the open end of the bypass is closed.

FIGS. 7-12 show a second embodiment of the device for making ananastomosis by mechanical means, wherein annular element 1 is a single,sinusoidal, elongated element 8, which expands in circumferentialdirection. Just like the elongated elements 2 and 3 of the firstembodiment, the sinusoidal, elongated element 8 according to this secondembodiment has a length dimension which is greater than thecircumferential dimension of the annular element in the startingposition thereof, and said length dimension of element 8 is at leastequal to the circumferential dimension of the annular element in thejoining position.

The sine shape of elongated element 8 is such that a number of vertices9 is positioned centrally in annular element 1, seen in axial view, onwhich vertices 9 pin-shaped elements 10 and 11 are formed, with twopin-shaped elements 10, 11, which form a pair, being spaced apart attheir free ends, seen in axial view, and meeting on elongated element 8at their bottom ends. Pin-shaped elements 10 and 11 may be provided witha point or other projection 12 at their free ends, on facing sides, soas to be fixed in a vessel wall.

When said annular element 1 according to FIGS. 7-12 is expanded from thefirst starting diameter to the second, larger diameter, the ends of thepin-shaped elements 10, 11 of a pair are not automatically movedtogether, so that it will be necessary to use an applicator which iscapable of closing the pin-shaped elements 10, 11 prior to,simultaneously with, or after the expansion of annular element 1 so asto clamp down the walls of the adjacent vessels therebetween for makingthe anastomosis.

FIGS. 13-15 show an embodiment of an applicator which can be used forthat purpose. The applicator is provided with a preferably rigid,shank-like element 13, on the proximal end of which means are providedfor manipulating the applicator, such as a grip, and on the distal endof which a head 14 is formed. Head 14 is provided with two axiallyspaced-apart hubs 15, 16, one of which, for example hub 16, is capableof axial movement, which movement is controlled from the proximal end ofshank-like element 13. Rigid arms 17 are arranged on hubs 15 and 16 in astar-like fashion, wherein pairs of associated arms 17 of the two hubs15 and 16 present at corresponding circumferential positions arepivotally interconnected in a point some distance away from their freeends. Arms 17 are also pivotally connected to hubs 15 and 16, with thepivots extending tangentially with respect to shank-like element 13. Inthis manner clips are formed.

FIG. 14 shows that annular element 1 is placed on the head 14 of theapplicator in such a manner that pin-shaped elements 10 and 11 arepositioned between the free ends of arms 17, past a pivot 18, as aresult of which the arms are pressed outwards from the position shown inFIG. 13 to the position shown in FIG. 15 upon movement of the hub, as aresult of which elongated element 8 is straightened to a shape whichextends more in circumferential direction, thereby enlarging thediameter, whilst the reduction of the angle between arms 17 of a pair ofarms results in a reduced angle between pin-shaped elements 10 and 11,and the free ends of pin-shaped elements 10 and 11 are moved together,eventually clamping the two walls of the adjacent vessels between them.The placement and removal of the applicator is carried out in a mannerwhich is comparable with the method described with reference to FIGS.1-6.

FIGS. 16-21 show a third embodiment of the device according to theinvention, which can be used for intraluminal placement in the case of aside-to-side anastomosis, but in particular also for extraluminalplacement in the case of an end-to-side anastomosis.

In this case, annular element 1 consists of a circular, elongatedelement 19, which is circumferentially provided in a number of placeswith pin-shaped elements 20, which axially project to one side from saidelongated element 19. The pins may be provided with points 21 thereby,whilst the pin-shaped elements 20 may be flat, or possibly round or thelike. As is shown in FIGS. 19-21, the pin-shaped elements 20 are inlarge measure bent radially outwards in the joining position of thedevice, but they may also be bent tangentially.

In order to be able to deform the pin-shaped elements 20 from thestarting position to the joining position, the applicator according toFIGS. 22-24 is provided. Also this applicator is provided with ashank-like element 13 and a head 14, but in this embodiment said head isprovided with a detainer 23 in the form of a sleeve to be positionedproximally with respect to annular element 1, which is attached to thehead, and with deflector elements 24, which can be moved at leastaxially, but preferably axially as well as radially, which deflectorelements can be manipulated from the proximal end of shank-like element13. Said deflector elements 24 consist of a fixed hub 25, an axiallymovable hub 26 and arms 27 which are pivoted together and connected tohubs 25, 26, which arms can be brought into engagement with thepin-shaped elements 20, and which can be deflected from an axialposition to a radial position, wherein annular element 1 is stopped bydetainer 23.

When the device according to FIGS. 16-21 and the applicator according toFIGS. 22-24 are used for making a side-to-side anastomosis, annularelement 1 is placed intraluminally, and the pin-shaped elements 20 arepassed through the vessel walls in places surrounding the openings thathave been formed by incisions. When the pin-shaped elements 20 aresubsequently bent radially outwards, it is no longer possible to removeannular element 1, because elongated element 19 is positioned inwardlyof the wall of one vessel and the radially projecting pin-shapedelements 20 are positioned inwardly of the wall of the other vessel.

In the case of an end-to-side anastomosis, the annular element 1 is slidover the bypass. The bypass is everted around annular element 1 and thepin-shaped elements are passed through the wall of the bypass andthrough the wall of the vessel to be anastomosed (for example theaorta). Pin-shaped elements 20 can be deflected by extension of thedeflector elements 24 of the applicator, and the walls will be fixedwith respect to each other.

FIGS. 25-27 show a variant of the applicator according to FIGS. 13-15which is suitable for placing an annular element 1 of a device of thetype as shown in FIGS. 1-6 (shown at the bottom of FIGS. 25 and 27) orin FIGS. 7-12 (shown at the top of FIGS. 25 and 27). Also in thisembodiment, a head 14 is attached to the shank 13 of the applicator.Said head 14 possesses a blunt end part 28 in this embodiment, which isfixed to shank 13 and also to a housing 29. The fixed connection betweenshank 13 and housing 29 is schematically illustrated by means of pin 30.A number of slots, eight in the illustrated embodiment, arecircumferentially provided, in regularly spaced-apart relationship, inend part 28 and in housing 29. Said slots 31 are wide enough forreceiving wedges 32, whereby it is important that slots 31 in end part28 have the same angle of inclination as the distal front face 33 ofwedges 32. Wedges 32 are radially held together by an elastic annularband 34. A control element 35 in the shape of a hollow shaft which canbe slid over shank 13 comprises a bevelled front face 36 at the distalend, which is capable of cooperation with a complementary bevel 36′ onthe proximal end of wedges 32. The angle of inclination of bevel 36′ andthe front face 36 is smaller than that of the distal front face 33 ofwedges 32.

An annular element 1 positioned in the applicator can be expanded fromthe starting position to the joining position by pressing wedges 32outwards. This can be effected by moving control element 35 distallyforwards, which control element presses wedges 32 outwards, via bevels36′, with its inclined front face 36, whereby the direction of themovement of wedges 32 corresponds with the direction of front faces 33and the cooperating surfaces of end part 28. The combined axial andradial movement of wedges 32 causes the annular element surroundingwedges 32 both to expand radially and to be clamped together between theadjacent housing surface and the wedge surface, as a result of whichpin-shaped elements 5, 6 and 10, 11 respectively of annular element 1are moved together, clamping the vessel walls down between them. Whencontrol element 35 moves back, the elastic band 34 causes wedges 32 toreturn to the starting position. Thus, the applicator can be withdrawnfrom annular element 1 and be removed in a simple and reliable manner.

FIGS. 28-30 show a variant of the applicator according to FIGS. 22-24,which can be used in combination with an annular element 1 of the typeaccording to FIGS. 16-21. The head 14 of this variant comprises a hollowshaft 37, with a blunt end part 38 present at the distal end thereof.Rectangular openings 39 (eight, for example) are provided in regularlyspaced-apart relationship in the circumference of hollow shaft 37. Saidhollow shaft 37 can move axially with respect to a housing 40, whosedistal end surface 41 can serve as an anvil for annular element 1.Wedges 42 are placed in openings 39, which wedges are pivoted to thehollow shaft by means of resiliently flexible plates 43, in such amanner that wedges 42 can move outwards about a substantially tangentialaxis, from their starting position (FIG. 28) in openings 39 to a joiningposition (FIG. 30) in the direction of housing 40. Said movement iseffected by moving a control element 44 in the form of a bar comprisinga bevelled point 45 in forward direction, as a result of which thewedges are tilted outwards through 90°, in which joining position theyare locked by the circumference of said control element 44. When housing40 is moved axially forward with respect to hollow shaft 37, in thedirection of wedges 42, the pin-shaped elements 20 of annular element 1will come into contact with the wedges 42, and the pin-shaped elements20 will be deflected outwards in a desired manner by the speciallyformed cavities 46 present in said wedges so as to fix annular element 1of the device to the vessel walls. Wedges 42 will return to the startingposition when control element 44 is withdrawn, and the applicator can beremoved. In principle it would also be possible to effect directdeflection of pin-shaped elements 20 through expansion of wedges 42.

FIGS. 31-36 show another variant of an applicator, which can for examplebe used for inserting the device according to FIGS. 1-6 or 7-12. Theapplicator is therefore arranged for effecting a radial expansion ofannular element 1 of the device and subsequently clamping together thejoining means, such as pin-shaped elements 5, 6 or 10, 11, in axialdirection or deforming them in some other manner. The difference withthe preceding embodiments of the applicator is the fact that theembodiment according to FIGS. 31-36 is arranged for effecting the radialand axial deformations of the device in two separate steps. First theannular element 1 is radially expanded, and then the joining means aremoved to their joining position. The advantage of this embodiment is thefact that the joining means are prevented from closing prematurely andthus missing part of the vessel wall.

In FIGS. 31-36, shank-like element 13, head 14 and detainer 23 can bedistinguished. An end portion 47 having a convex end surface is formedon the distal end of shank-like element 13, whilst end part 47 iswedge-shaped or conical on proximal side 48. Besides shank-like element13 and detainer 23, a third, relatively movable part 49 is provided,which can be moved both with respect to shank-like element 13 and withrespect to detainer 23 from a control position outside the body. Part 49and/or detainer 23 are circumferentially provided with a number ofradially extending slots 50 for movably accommodating, at least in part,an equal number of arms 51. Arms 51 can move between the innermoststarting position, in which they abut against a conical surface 52 ofmovable part 49, and an outermost joining position, in which they abutagainst the inner wall of detainer 23 (FIGS. 32, 33). Arms 51 comprisean outwardly curved deflection surface 53 near their distal ends, whichis to mate with pin-shaped elements of annular element 1, which may beprovided round arms 51, adjacently to deflection surfaces 53. An elasticband 54 (see FIGS. 35, 36) may extend through radial notches 55 presentnear the distal ends of arms 51, which band functions to cause arms 51to spring back to an inward position.

As is shown in FIG. 34, it is also possible to use arms which areinterconnected by an annular part 56 at their proximal ends instead ofseparate arms 51. This one-piece assembly may for example be in the formof a plastic moulding, whereby the pivoting movement of arms 51 is madepossible by the elastic properties of the relatively long arms. Slots 50are no longer required in this manner, since annular part 56 holds arms51 in position.

The operation of the applicator is as follows. In the position as shownin FIG. 31, the applicator and the annular element 1 of the device,which is present thereon (not shown), are moved to their destination,and then the shank-like element 13 and the end part 47 are withdrawn inproximal direction with respect to part 49 (or part 49 is extended), andarms 51 are pressed radially outwards by the mating cooperation betweenthe wedge-shaped proximal side 48 of end part 47 and the associatedwedge-shaped surfaces of arms, because arms 51 are supported against ashoulder of part 49 (see FIG. 32). Annular element 1 is thereby deformedradially outwards by arms 51 to a larger diameter. Detainer 23 is thenmoved relative to shank-like element 13 and part 49, as a result ofwhich the end face of detainer 23 is moved in the direction of thedeflection surfaces and the joining means are deformed in such a mannerthat the vessel walls of the hollow structures are interconnected. Whenshank-like element 13 and part 49 are moved apart again, elastic band 54will return arms 51 to their starting position as shown in FIG. 31.

With the applicator according to FIGS. 37-40, the isovolumetricbehaviour of some elastic and readily deformable material, such asrubber, is utilized for the radial expansion of annular element 1 of thedevice. The axial compression of the material will result in axialcontraction and, if inward deformation is not possible, to radiallyoutward expansion. In the illustrated embodiment, an isovolumetric core57 is provided, on which annular element 1 of the device can be placed.Head 14 of said applicator furthermore comprises a sleeve 58 which isaxially movable with respect to shank-like element 13, which sleevecomprises an end part 59 capable of cooperation with an end part 60 ofshank-like element 13. Pivoted radial supports 61 are connected to theassociated end parts 59, 60, they support circumferentially providedplates 62, which are held together by an associated elastic band 63,which also provides the return force. By moving the end parts 59, 60together, the plates 62 are moved from the original sloping position asshown in FIGS. 38, 40 to an eventual joining position as shown in FIGS.37, 39, wherein said plates extend practically perpendicularly toshank-like element 13. The facing surfaces of plates 62 are then capableof deforming the joining means upon further movement of end parts 59, 60towards each other when the isovolumetric core 57 is compressed and theannular element is expanded thereby and, as already mentioned before,the joining means are moved to their joining position. This embodimentof the applicator is suitable for drastic miniaturisation.

FIG. 41 shows the result of a side-to-side anastomosis of two hollowstructures, such as blood vessels, wherein loose staples 64 are used asjoining means for the vessel walls. One of the above-describedapplicators may be used, providing that means are used for holding thestaples 64 correctly spaced apart when said staples 64 are beinginserted and moved to their joining position. Also in this embodimentthe staples are placed intraluminally, whilst a guide wire may be usedfor moving the applicator to its correct position.

From the above it will have become apparent that the invention providesa system for making anastomoses between hollow structures by mechanicalmeans, by means of which system an anastomosis can be made in a quickand reliable manner, as a result of which the negative effects of ananastomosis for the patient are minimized and the system is suitable fora large number of applications.

The invention is not limited to the above-described embodiments as shownin the drawing, which can be varied in several ways within the scope ofthe invention. Thus, the expandable version of the device might also bemade of a resilient material or of a shape-memorizing metal, so that thedevice can move to the expanded position without external forces beingexerted when the device is being provided. The elongated elements maynot be recognizable as such, but they may be encountered in a differenttype of structure.

What is claimed is:
 1. A device for use in a system for makinganastomoses between hollow structures having walls, comprising: a hollowelement having a tubular or annular shape and a longitudinal axis, saidhollow element being movable from a starting position having a firstcross-sectional area to a joining position having a second, largercross-sectional area, said cross-sectional areas being viewed in anaxial direction; and a plurality of joining elements distributedcircumferentially on the hollow element, as viewed in an axialdirection, and which are movable from a starting position to a joiningposition in order to hold the abutting walls of said hollow structurestogether, and wherein each said joining element has at least two freeends associated as a set at a single position on the hollow element andeach set of at least two free ends of said joining elements are spacedapart when the joining elements are positioned in the starting positionand each set of at least two free ends of each said joining element arepositioned closer together when the joining elements are positioned inthe joining position than said free ends are positioned when saidjoining elements are in the starting position in order to hold the wallsof said hollow structures together.
 2. A device as claimed in claim 1,wherein each said hollow element has a substantially circularcross-sectional shape, as viewed in an axial direction.
 3. A device asclaimed in claim 1, wherein each said hollow element has a substantiallyelliptical cross-sectional shape, as viewed in an axial direction.
 4. Adevice as claimed in claim 1, wherein each said hollow element has asubstantially polygonal cross-sectional shape, as viewed in an axialdirection.
 5. A device as claimed in claim 1, wherein each said joiningelement comprises a plurality of pin-shaped elements and each saidpin-shaped element is movable from a starting position to a joiningposition.
 6. A device as claimed in claim 5, wherein each saidpin-shaped element extends in a substantially axial direction relativeto said hollow element, when said hollow element is in the startingposition and wherein each said pin-shaped element is caused to deform toextend in a direction relative to said hollow element, which is selectedfrom a substantially radial direction and a substantially tangentialdirection, when said hollow element is in said joining position.
 7. Adevice as claimed in claim 1, wherein said hollow element is permanentlydeformed when moved from said starting position to said joiningposition.
 8. A device for use in a system for making anastomoses betweenhollow structures having walls, comprising: a hollow element having atubular or annular shape and a longitudinal axis, said hollow elementbeing made up only of two elongate elements, each said elongate elementhaving vertices, and a shape selected from the group consisting ofzigzag-like and sinusoidal, said elongate elements being arrangedside-by-side in an axial direction and being interconnected at or nearthe vertices of said elongate elements that face each other, said hollowelement being movable from a starting position having a firstcross-sectional area to a joining position having a second, largercross-sectional area, said cross-sectional areas being viewed in anaxial direction; and a plurality of joining elements distributedcircumferentially on the hollow element, as viewed in the axialdirection, and which are movable from a starting position to a joiningposition in order to hold the abutting walls of said hollow structurestogether, and said joining elements being fixed only at the vertices ofthe elongate elements that face away from each other.
 9. A device asclaimed in claim 8, wherein said hollow element is deformable from saidstarting position to said joining position by causing each elongateelement to be straighter when in said joining position than the samesaid elongate element when in said starting position.
 10. A device asclaimed in claim 8, wherein each said elongate element has a zigzag-likeshape, as viewed from a side.
 11. A device as claimed in claim 8,wherein each said elongate element has a sinusoidal shape, as viewedfrom a side.
 12. A device as claimed in claim 8, wherein each saidhollow element has a substantially circular cross-sectional shape, asviewed in an axial direction.
 13. A device as claimed in claim 8,wherein each said hollow element has a substantially ellipticalcross-sectional shape, as viewed in an axial direction.
 14. A device asclaimed in claim 8, wherein each said hollow element has a substantiallypolygonal cross-sectional shape, as viewed in an axial direction.
 15. Adevice as claimed in claim 8, wherein each said joining elementcomprises a plurality of pin-shaped elements and each said pin-shapedelement is movable from a starting position to a joining position.
 16. Adevice as claimed in claim 15, wherein each said pin-shaped elementextends in a substantially axial direction relative to said hollowelement, when said hollow element is in the starting position andwherein each said pin-shaped element is deformed to extend in adirection relative to said hollow element, which is selected from asubstantially radial direction and a substantially tangential direction,when said hollow element is in said joining position.
 17. A device asclaimed in claim 15, wherein two of said pin-shaped elements areassociated as a pair at a single position on said hollow element andeach said pin-shaped element includes a free end, and wherein the freeends of each said associated pair of pin-shaped elements are spacedapart from one another in the starting position, as measured in an axialdirection, and said free ends are closer together in the joiningposition than in said starting position, as measured in an axialdirection.
 18. A device as claimed in claim 8, wherein said hollowelement is permanently deformed when moved from said starting positionto said joining position.
 19. A device as claimed in claim 18, whereinsaid elongate element has a length which is greater than a circumferenceof said hollow element, as measured when said hollow element is in thestarting position, and said elongate element has a length which issubstantially the same as a circumference of said hollow element whensaid hollow element is in the joining position.
 20. A device as claimedin claim 18, wherein each said elongate element is straighter when in ajoining position than the same elongate element when in a startingposition.
 21. A device for use in a system for making anastomosesbetween abutting walls of hollow structures, comprising: a hollowelement having an annular or tubular shape and including only a pair ofprimary elements arranged side-by-side along the circumference of thehollow element to form the annular or tubular hollow element, each saidprimary element having an elongate shape deviating from a straight lineto form primary vertices on a first side of said primary element, andsecondary vertices on a second, opposite side of said primary element,as viewed in an axial direction relative to each said primary element,said primary and secondary vertices being staggered about thecircumference of said hollow element, said primary elements beinginterconnected at the secondary vertices to form a pair, and said hollowelement is movable from a starting position wherein said device has afirst cross-sectional area to a joining position wherein said device hasa second, larger cross-sectional area, said cross-sectional areas beingviewed in an axial direction relative to said anastomosis device, byincreasing the distance between said secondary vertices, as viewed in anaxial direction relative to said hollow element; and joining elementsformed circumferentially on the hollow element for joining the abuttingwalls of the hollow structures together, said joining elements beingfixed only at the primary vertices of each of said primary elements thatface away from each other, said joining elements being movable between astarting position and a joining position in order to hold the abuttingwalls of the hollow structures together.
 22. A device as claimed inclaim 21, wherein said hollow element is permanently deformed when movedfrom said starting position to said joining position.
 23. A device asclaimed in claim 22, wherein said elongate element has a length which isgreater than a circumference of said hollow element, as measured whensaid hollow element is in the starting position, and said elongateelement has a length which is substantially the same as a circumferenceof said hollow element when said hollow element is in the joiningposition.
 24. A device as claimed in claim 22, wherein each saidelongate element is straighter when in a joining position than the sameelongate element when in a starting position.
 25. A device as claimed inclaim 24, wherein each said pin-shaped element extends in asubstantially axial direction relative to said hollow element, when saidhollow element is in the starting position and wherein each saidpin-shaped element is deformed to extend in a direction relative to saidhollow element, which is selected from a substantially radial directionand a substantially tangential direction, when said hollow element is insaid joining position.
 26. An applicator for use with a device forintraluminally making anastomoses between abutting walls of hollowstructures, said device including joining elements to hold the abuttingwalls of the hollow structures together, said applicator comprising: ashank-like element; a head located at a distal end of the shank-likeelement for supporting the device to be positioned thereon and foractivating the joining elements, said head being radially expandable,and having an axially-contractible element adapted to move said joiningelements of the device from a starting position to a joining position inorder to hold the abutting walls of the hollow structures together; acontrol element for controlling the radial expansion of the head of theapplicator, and for controlling the axially-contractible element of thehead; wherein the joining elements comprise a plurality of pin-shapedelements which are provided in associated pairs on a hollow element, andeach associated pair of said pin-shaped elements has two free ends whichare spaced apart when said applicator is in a starting position; andwherein the axially-contractible element of said applicator is adaptedto move at least the free ends of each associated pair of pin-shapedelements towards each other to a joining position.
 27. A method formaking anastomoses intraluminally between abutting walls of hollowstructures, said method comprising the steps of: providing an applicatorand associated joining means for joining the abutting walls of thehollow structures together, placing said joining means around theapplicator in a starting position, inserting said applicator and saidjoining means into each of said hollow structures to a location internalto the wall of each said hollow structure, and activating saidapplicator to move said joining means by expanding the cross-sectionalarea of said applicator, as viewed in an axial direction, andconsecutively moving each joining means from the starting position tothe joining position by moving at least a portion of at least one of anassociated pair of joining means closer to a portion of the other of anassociated pair of joining means to thereby clamp the abutting walls ofthe hollow structures in sealing contact with each other.
 28. The methodaccording to claim 27, used to make side-to-side anastomoses.
 29. Themethod according to claim 27, used to make end-to-side anastomoses. 30.A method for making anastomoses intraluminally between abutting walls ofhollow structures, said method comprising the steps of: providing anapplicator and an associated anastomosis device having a plurality ofjoining elements for joining the abutting walls of the hollow structurestogether, placing said anastomosis device around the applicator in astarting position, inserting said applicator and said anastomosis deviceinto each of said hollow structures to a location internal to the wallof each said hollow structure, and activating said applicator to movethe anastomosis device from a starting position wherein said device hasa first cross-sectional area to a joining position wherein said devicehas a second, larger cross-sectional area, said cross-sectional areasbeing viewed in an axial direction relative to said anastomosis device,and simultaneously moving pairs of the joining elements towards eachother to clamp the abutting walls of said hollow structures in sealingcontact with each other.
 31. The method according to claim 30, used tomake side-to-side anastomoses.
 32. The method according to claim 30,used to make end-to-side anastomoses.
 33. The method according to claim30, wherein the anastomosis device has a cross-sectional shape selectedfrom the group consisting of substantially circular, substantiallyelliptical and substantially polygonal, as viewed in an axial directionrelative to said anastomosis device.
 34. The method according to claim33, wherein the joining elements include pin-shaped elements providedcircumferentially around the anastomosis device, and wherein thepin-shaped elements are moved together in an axial direction to clampthe abutting walls therebetween in said step of activating theapplicator.
 35. A method as claimed in claim 30, wherein said hollowelement is permanently deformed when moved from said starting positionto said joining position.
 36. A method for making anastomosesintraluminally between abutting walls of hollow structures, said methodcomprising the steps of: providing an applicator and an associatedanastomosis device having a plurality of joining elements for joiningthe abutting walls of the hollow structures together, placing saidanastomosis device around the applicator in a starting position,inserting said applicator and said anastomosis device into each of saidhollow structures to a location internal to the wall of each said hollowstructure, and activating said applicator to move the anastomosis devicefrom a starting position wherein said device has a first cross-sectionalarea to a joining position wherein said device has a second, largercross-sectional area, said cross-sectional areas being viewed in anaxial direction relative to said anastomosis device, and subsequentlymoving pairs of the joining elements towards each other to clamp theabutting walls of said hollow structures in sealing contact with eachother.
 37. A method as claimed in claim 36, wherein said hollow elementis permanently deformed when moved from said starting position to saidjoining position.
 38. The method according to claim 36, used to makeside-to-side anastomoses.
 39. The method according to claim 36, used tomake end-to-side anastomoses.
 40. The method according to claim 36,wherein the anastomosis device has a cross-sectional shape selected fromthe group consisting of substantially circular, substantially ellipticaland substantially polygonal, as viewed in an axial direction relative tosaid anastomosis device.
 41. The method according to claim 40, whereinthe joining elements include pin-shaped elements providedcircumferentially around the anastomosis device, and wherein thepin-shaped elements are moved together in an axial direction to clampthe abutting walls therebetween in said step of activating theapplicator.
 42. A method for making anastomoses intraluminally betweenabutting walls of hollow structures, said method comprising the stepsof: providing an applicator and an associated anastomosis device forjoining the abutting walls of the hollow structures together, saiddevice including a hollow element and a plurality of joining elementsprovided circumferentially on said hollow element, placing said hollowelement around the applicator in a starting position, inserting saidapplicator and said device into each of said hollow structures to alocation internal to the wall of each said hollow structure, andactivating said applicator to first expand the hollow element from astarting position wherein said device has a first cross-sectional areato a joining position wherein said device has a second, largercross-sectional area, said cross-sectional areas being viewed in anaxial direction relative to said anastomosis device, and subsequentlymoving the joining elements towards each other from a starting positionto a joining position to thereby clamp the abutting walls of said hollowstructures in sealing contact with each other.
 43. A method as claimedin claim 42, wherein said hollow element is permanently deformed whenmoved from said starting position to said joining position.
 44. Themethod according to claim 42, used to make side-to-side anastomoses. 45.The method according to claim 42, used to make end-to-side anastomoses.46. The method according to claim 42, wherein said hollow element isannular or tubular.
 47. The method according to claim 46, wherein theanastomosis device has a cross-sectional shape selected from the groupconsisting of substantially circular, substantially elliptical andsubstantially polygonal, as viewed in an axial direction relative tosaid anastomosis device.
 48. The method according to claim 47, whereinthe joining elements include pin-shaped elements providedcircumferentially around the anastomosis device, and wherein thepin-shaped elements are moved together in an axial direction to clampthe abutting walls therebetween in said step of activating theapplicator.
 49. A method for intraluminally making anastomoses betweenabutting walls of hollow structures, said method comprising the stepsof: providing an applicator and an associated anastomosis device forjoining the abutting walls of the hollow structures together, saiddevice including a hollow element and a plurality of associated pairs ofjoining elements provided circumferentially thereon, placing said hollowelement around the applicator in a starting position, inserting saidapplicator and said device into each of said hollow structures to alocation internal to the wall of each said hollow structure, andactivating said applicator to first expand the hollow element from astarting position wherein said device has a first cross-sectional areato a joining position wherein said device has a second, largercross-sectional area, said cross-sectional areas being viewed in anaxial direction relative to said anastomosis device, and simultaneouslymoving the joining elements from a starting position to a joiningposition whereby the associated pairs of joining elements move towardseach other such as to clamp the abutting walls of the hollow structuresin sealing contact with each other.
 50. A method as claimed in claim 49,wherein said hollow element is permanently deformed when moved from saidstarting position to said joining position.
 51. The method according toclaim 49, used to make side-to-side anastomoses.
 52. The methodaccording to claim 49, used to make end-to-side anastomoses.
 53. Themethod according to claim 49, wherein said hollow element is annular ortubular.
 54. The method according to claim 53, wherein the anastomosisdevice has a cross-sectional shape selected from the group consisting ofsubstantially circular, substantially elliptical and substantiallypolygonal, as viewed in an axial direction relative to said anastomosisdevice.
 55. The method according to claim 54, wherein the joiningelements include pin-shaped elements provided circumferentially aroundthe anastomosis device, and wherein the pin-shaped elements are movedtogether in an axial direction to clamp the abutting walls therebetweenin said step of activating the applicator.
 56. A method forintraluminally making anastomoses between abutting walls of hollowstructures, said method comprising the steps of: providing an applicatorand an associated anastomosis device for joining the abutting walls ofthe hollow structures together, said device including a hollow elementand joining elements provided circumferentially thereon, placing saidhollow element around the applicator in a starting position, insertingsaid applicator and said device into each of said hollow structures to alocation internal to the wall of each said hollow structure, andactivating said applicator to first move associated pairs of the joiningelements towards each other from a starting position to a joiningposition to thereby clamp the abutting walls of the hollow structures insealing contact with each other, and subsequently expanding the hollowelement from a starting position wherein said device has a firstcross-sectional area to a joining position wherein said device has asecond, larger cross-sectional area, said cross-sectional areas beingviewed in an axial direction relative to said anastomosis device. 57.The method according to claim 56, used to make side-to-side anastomoses.58. The method according to claim 56, used to make end-to-sideanastomoses.
 59. The method according to claim 56, wherein said hollowelement is annular or tubular.
 60. The method according to claim 59,wherein the anastomosis device has a cross-sectional shape selected fromthe group consisting of substantially circular, substantially ellipticaland substantially polygonal, as viewed in an axial direction relative tosaid anastomosis device.
 61. The method according to claim 60, whereinthe joining elements include pin-shaped elements providedcircumferentially around the anastomosis device, and wherein thepin-shaped elements are moved together in an axial direction to clampthe abutting walls therebetween in said step of activating theapplicator.